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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended treatment | Experimental | 52-week varenicline therapy + individual smoking cessation counseling |
|
| Standard treatment | Active Comparator | 13 weeks of varenicline therapy + individual smoking cessation counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | Extension of 1 mg twice daily treatment to 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 | Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of < 10 parts per million as assessed at Week 52 | 7-day point prevalence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Tobacco Research and Intervention | Madison | Wisconsin | 53711 | United States | ||
| Center for Tobacco Research and Intervention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Treatment | 52-week varenicline therapy + individual smoking cessation counseling |
| FG001 | Standard Treatment | 13 weeks of varenicline therapy + individual smoking cessation counseling |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Treatment | 52-week varenicline therapy + individual smoking cessation counseling |
| BG001 | Standard Treatment | 13 weeks of varenicline therapy + individual smoking cessation counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 | Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of < 10 parts per million as assessed at Week 52 | Participants randomized at 12 weeks who continued in the study to Week 52 and provided CO-verified smoking status. | Posted | Number | participants | 7-day point prevalence |
|
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Number of participants at risk based upon those available to be randomized at Week 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extended Treatment | 52-week varenicline therapy + individual smoking cessation counseling |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Motor Vehicle Accident | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Feasibility study with limited statistical power at baseline compounded by a significant rate of attrition during the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas E. Jorenby, Ph.D. | University of Wisconsin School of Medicine and Public Health | 6082627527 | dej@ctri.medicine.wisc.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| varenicline | Drug | Double-blind switch to placebo after 12 weeks of open-label therapy |
|
| Individual smoking cessation counseling | Behavioral | Brief (<10 minutes) smoking cessation counseling delivered at clinic visits |
|
| Milwaukee |
| Wisconsin |
| 53233 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 1 |
| 33 |
| 13 |
| 33 |
| EG001 | Standard Treatment | 13 weeks of varenicline therapy + individual smoking cessation counseling | 1 | 34 | 12 | 34 |
| Bladder Surgery | Renal and urinary disorders | Systematic Assessment | Occurred two months into nontreatment follow-up phase |
|
| General Disorders NOS | General disorders | Systematic Assessment |
|
| Upper Respiratory Tract Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Metabolism NOS | Metabolism and nutrition disorders | Systematic Assessment |
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| Infection NOS | Infections and infestations | Systematic Assessment |
|
| Musculoskeletal NOS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
|
| Injuries | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D011810 | Quinoxalines |